Fovinaciclib with endocrine therapy and HER2 blockade for HR+/HER2+ early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, response-adapted neoadjuvant trial in HR-positive/HER2-positive breast cancer. All participants start with fovinaciclib plus an aromatase inhibitor and dual HER2 blockade, followed by an early response assessment at 6 weeks. Responding patients continue the same regimen; non-responders switch to standard neoadjuvant chemotherapy with HER2-targeted therapy before surgery. The study uses an adaptive algorithm to maximize benefit and minimize unnecessary chemotherapy, with outcomes including tumor response and safety. Eligible patients are adults up to age 75 with AJCC stage I-III disease and measurable lesions, ECOG 0-1, and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria Subjects voluntarily agree to participate in the study, fully understand the study procedures, provide written informed consent (ICF), and are willing and able to comply with all study procedures.

Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage or locally advanced invasive breast cancer.

Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.

Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator assessment.

Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Ability to swallow capsules.

Adequate bone marrow and organ function, defined as follows:

Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; Hemoglobin ≥100 g/L (without red blood cell transfusion within 14 days prior to randomization); Platelet count ≥100 × 10\^9/L; Total serum bilirubin ≤1.5 × upper limit of normal (ULN); patients with Gilbert syndrome must have total bilirubin ≤3 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN; Serum creatinine \<1.5 × ULN or creatinine clearance ≥50 mL/min; Left ventricular ejection fraction (LVEF) ≥50%; QT interval ≤480 ms. Exclusion Criteria Current participation in another clinical trial involving investigational therapy, or participation in any other medical study considered scientifically or medically incompatible with this study.

Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. History of uncontrolled seizures or central nervous system disease. History of other malignancies within the past 5 years. Pregnant or breastfeeding women. Known severe hypersensitivity to any component of the study drugs. Severe comorbidities, including uncontrolled hypertension (e.g., systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg), uncontrolled diabetes mellitus, or active infection. Patients with adequately controlled hypertension may be enrolled.

Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention within 2 weeks prior to first dosing.

Myocardial infarction within 6 months prior to first dosing; uncontrolled arrhythmia (QTc ≥470 ms, calculated using Fridericia's formula); New York Heart Association (NYHA) class III-IV heart failure; LVEF \<50%; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention.

Dysphagia, active gastrointestinal disease, history of major gastrointestinal surgery, malabsorption syndrome, or any condition that may affect absorption of study drugs.

Active hepatitis B infection \[HBsAg-positive with detectable HBV-DNA\], active hepatitis C infection \[HCV antibody-positive with detectable HCV-RNA\], positive syphilis screening (except confirmed inactive infection), known HIV infection, or positive HIV screening result.

Receipt of major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody-based antitumor therapy, or other systemic antitumor therapies considered by the investigator to interfere with study treatment efficacy within 28 days prior to first dosing.

Planned or previous organ transplantation or bone marrow transplantation. Known history of psychiatric substance abuse or drug addiction. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• 2nd Affiliated Hospital, School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Ningbo No. 2 Hospital
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yunxiang Zhou
• Email: yxzhou@zju.edu.cn
• Phone: 15868131018

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether typology-based coaching helps people with HR+/HER2- early breast cancer stay on ribociclib plus an aromatase inhibitor longer than standard education alone.

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• Culmerciclib plus aromatase inhibitors for early ER-positive/HER2-negative breast cancer

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• Improving outcomes for women with high‑risk HR+ early breast cancer taking abemaciclib

  This project looks back at medical records to see if women with high‑risk HR+/HER2‑ early breast cancer are still taking abemaciclib six months after they start treatment.

  Recruiting Institut fuer Frauengesundheit · Erlangen, Bavaria · NCT07531693

• See if standardized coaching helps patients stick with abemaciclib

  This study tests whether structured patient coaching helps women with early HR+/HER2- breast cancer take abemaciclib more reliably alongside endocrine therapy.

  Recruiting at 8 sites Institut fuer Frauengesundheit · Esslingen am Neckar, Baden-Wurttemberg and 7 other locations · NCT07521202

• Ribociclib plus hormone therapy for HR+/HER2- early breast cancer in Saudi Arabia

  This study will try to see if adding ribociclib to standard adjuvant hormone therapy is effective and safe for adults in Saudi Arabia with HR+/HER2- early breast cancer.

  Recruiting at 2 sites Novartis · Riyadh and 1 other locations · NCT06797531

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.